FDAClass IIJanuary 11, 2023

Acyclovir Sodium Injection 1 recall: Particulate Matter

Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

Why was Acyclovir Sodium Injection 1 recalled?

Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # AC22004, Expiry: 08/2023

Product
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
Recalling firm
Eugia US LLC
Quantity
45,250 vials
Distribution
Nationwide in the USA
Recall date
January 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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